Effect of Allopurinol Treatment on Insulin Resistance | NCT02008968

Studies
Effect of Allopurinol Treatment on Insulin Resistance

NCT02008968

Sponsor

Istanbul Medeniyet University

Status

Unknown status

Last Update Posted

Dec 11, 2013Estimated

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Hyperuricemia
Prediabetes
Insulin Resistance

Interventions

allopurinol 300 mg./day
No intervention
Normouricemic

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Aug 2014Estimated

First Submitted Date

Dec 7, 2013

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2013

Last Update Posted Date

Dec 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Kanbay, Associate Professor Doctor Mehmet Kanbay, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Uric acid ≥7 mg/dL	Active Comparator	This arm will receive allopurinol treatment. 50 subjects will be recruited.	Drug: allopurinol 300 mg./day
Uric acid ≥6 and <7	Active Comparator	This arm will not receive allopurinol. 50 subjects will be recruited.	Other: No intervention
Normouricemic	Placebo Comparator	This arm is healthy controls. 30 subjects will be recruited.	Drug: Normouricemic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
allopurinol 300 mg./day	Drug		Uric acid ≥7 mg/dL
No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in insulin resistance (HOMA-IR)		baseline and 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 30
Serum uric acid level ≥7mg/dL
Glomerular filtration rate ≥60 ml/min

Exclusion Criteria:

presence of Diabetes Mellitus
history of gout
history of allopurinol use
body mass index ≥35 kg/m2
proteinuria ≥ 1gr/ day
presence of autoimmune disease
rheumatology associated disease
presence of hypothyroidism or hyperthyroidism
presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mehmet Kanbay, Associate Professor	Contact	+902165709294		drkanbay@yahoo.com

Overall Officials

Name	Affiliation	Role
Ali Bakan	Istanbul Medeniyet University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medeniyet University Goztepe Training and Research Hospital	Recruiting	Istanbul	Marmara	34353	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D033461	Hyperuricemia
D011236	Prediabetic State
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided